DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Examiner acknowledges that, according to the Filing receipt received 04/11/2024, that the instant application 18/289,872 filed 11/07/2023 is a 371 of PCT/KR2022/005569 filed 04/19/2022 which claims foreign priority of Republic of Korea application 10-2021-0060990 filed 05/11/2021.
Information Disclosure Statement
The Information Disclosure Statement filed on 11/07/2023 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located on pages 16-17 of the specification filed 11/07/2023.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
Claim 1: “, or a pharmaceutically acceptable salt thereof” should read “; or a pharmaceutically acceptable salt thereof”.
Claim 3: "R2 to R9" should read "R.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein L is… C1-C5 alkylene”. The specification defines “alkylene” as “a divalent functional group. Specific examples of such alkylene groups include methylene, ethylene, propylene, butylene, and pentylene” (specification, p. 9) which suggests that alkylene is unsaturated (i.e., alkene). However, in the compounds depicted on pages 6-8 which are labeled as compounds of Formula 1, some of the compounds contain fully saturated aliphatic carbon chains in the L position (see, for example, 3C1, 3C2, etc.) which is consistent with the meaning of alkylene in the art. The scope of alkylene is unclear as it cannot be ascertained whether “alkylene” is a divalent alkane or a divalent alkene. Claims 2-9 do not clarify the limitation at issue and are also rejected. For the purposes of examination and searching prior art, Examiner has interpreted “alkylene” to mean both “alkyl” and “alkenyl”.
Claim 1 recites “C1-C10 monoalkyl”. It is unclear what functional group is intended here. Claims 2-9 recite and/or do not clarify the limitation at issue and are also rejected.
Claim 1 recites “C1-C10 dialkylamino”. It is unclear if C1-C10 means that each alkyl contains 1-10 carbons or if the dialkyl contains 1-10 carbons in total. Claims 2-9 recite and/or do not clarify the limitation at issue and are also rejected.
Claim 3 recites “R2 to R9 are as defined in claim 1”. However, claim 1 does not set forth definitions for R5 to R9. This limitation lacks antecedent basis.
Claim 9 recites “the respiratory diseases” and “the skin conditions”. These limitations lack antecedent basis.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8 and 9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 8 and 9 recite intended uses of the compound and composition thereof as in claims 1 and 7. An intended use is given minimal patentable weight and does not further limit the scope of the claims if it does not impart a structural limitation.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn a composition comprising a compound of general Formula 1 as below, for use in treating respiratory and skin conditions.
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The compounds of Formula 1 are drawn to variable substituents such as aryl and heteroaryl groups generally, which may be additionally substituted. However, the instant specification only sets forth compounds wherein R1 is phenyl, R2 is imidazolyl, and R3 is amino (pages 6-8). Applicant discloses that these compounds “enable more efficient control over the expression of inflammatory cytokine factors”, however, no consideration is given as to whether these properties would be maintained across a broader scope of compounds with different substituents within Formula 1.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). A review of the language of the claims indicates that these claims are drawn to a generic genus, i.e., generic formula for compounds.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 48 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (48 USPQe2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(i), the court states, "An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention."
The instantly claimed formula encompasses millions of possible compounds, where the very core part of the structure is established in Formula 1 but the substituent modifications vary greatly compared to the disclosed species. The species disclosed by Applicants are substantially narrower than all of the potential species as defined by the genus.
Generally, the lack of exemplified guidance establishes a reasonable level of doubt that would suggest that the Applicant was not in possession of the various species claimed and thus has not met the written description requirement. Although Applicants describe the compounds of Formula I generally and describe the exemplified embodied substituents, Applicant’s disclosure is silent regarding a number of functionality modifications to the claimed invention thus introducing uncertainty. Applicant does not provide a description that reasonably overcomes the factual understanding that is indicative of the state of the art and that shows that the given possible species, or any related synthon have yet to be established. One of skill in the art would find these factors important in considering the practical application of generating the proposed instantly claimed species. Thus, the claimed compound species of Formula I are neither within Applicant's possession nor reasonably supported by Applicant’s disclosure. While Applicant recites this broad, generic Formula I, Applicant provides no evidence of record that any of the species of this genus are in possession.
In the absence of sufficient guidance, the specification does not provide adequate written description of the claimed genus of Formula 1, which is a generic genus of compounds. One of ordinary skill in the art would not recognize from the disclosure that the Applicant was in possession of the genus. The specification does not clearly allow persons of ordinary skill in the art to recognize that they have invented what is claimed (see Vas-Cath at page 1116).
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating, does not reasonably provide enablement for preventing. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
It is presumed “prevention” of the claimed diseases would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted.
The factors to be considered in making an enablement rejection are summarized as follows.
1) As discussed above, preventing diseases requires identifying those patients who will acquire the disease before the respiratory disease or skin condition occurs. This would require extensive and potentially opened ended clinical research on healthy subjects. 2) The claim is directed toward both treatment and prevention. 3) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to clinical pharmacology and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will suffer from a respiratory disease or skin condition before the fact. 6) The artisan using Applicants invention would be a Board-Certified physician in oncological diseases with an MD degree. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of a respiratory disease or skin condition. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent a respiratory disease or skin condition. That is, the skill is so low that no compound effective generally against the prevention of a respiratory disease or skin condition. 7) It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved" and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed diseases.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kwak et al. (Food Chemistry; 2011).
Kwak et al. discloses antioxidative caffeoyl-proline dipeptides with the following core structure, including wherein R is histidine or tryptophan (Table 1; Fig. 1).
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The dipeptides wherein R is histidine or tryptophan have the following structures, as provided by STN (see Examiner’s search strategy).
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These compounds are within the scope of the claims wherein L is alkylene (ethylene, see instant specification cited above), R1 is phenyl disubstituted by hydroxyl, R2 is imidazolyl or indolyl, R3 is amino, and R4 is hydrogen. As discussed in the above 112(d) rejection, the intended use of the compounds and compositions thereof is not given substantial patentable weight. Moreover, per MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).” As such, the properties recited in claims 8 and 9 would be expected to be shared by the compounds of Kwak et al. which are substantially identical to the claimed invention.
Claim(s) 1-3 and 5-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gudasheva et al. (Pharmaceutical Chemistry Journal; 2006).
Gudasheva et al. discloses retropeptides with anxiolytic activity, including the structure as below wherein X is proline (Fig. 1).
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The compound wherein X is proline has the following structure, as provided by STN (see Examiner’s search strategy).
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The compound is within the scope of the claims wherein L is alkylenyl (pentyl, see above 112(b) rejection), R1 is phenyl, R2 is indolyl, R3 is amino, and R4 is hydrogen. Examiner additionally notes that the provisos in claims 2 and 3 are claimed as “optional” and are thus not required. As discussed in the above 112(d) rejection, the intended use of the compounds and compositions thereof is not given substantial patentable weight. Moreover, per MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).” As such, the properties recited in claims 8 and 9 would be expected to be shared by the compounds of Kwak et al. which are substantially identical to the claimed invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beeren et al. (ChemComm; 2011).
Beeren et al. discloses the following compound (Fig. 2a).
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The compound is within the scope of the claims wherein L is a bond, R1 is phenyl substituted by alkyloxy, R2 is indolyl, R3 is amino, and R4 is hydrogen. Examiner additionally notes that the provisos in claims 2 and 3 are claimed as “optional” and are thus not required. As discussed in the above 112(d) rejection, the intended use of the compounds and compositions thereof is not given substantial patentable weight. Moreover, per MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).” As such, the properties recited in claims 8 and 9 would be expected to be shared by the compounds of Kwak et al. which are substantially identical to the claimed invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Lee et al. (WO2011014025A2). An English translation is relied upon by the Examiner and has been attached to the prior art document.
Lee et al. discloses compounds of the following general formula I (p. 1, original document) wherein at least one of R1-R3 is OH, R4 is 2-16 amino acids, and R5 is NH2, NHOH, or OH (p. 2, English translation).
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Lee et al. further discloses species of formula I, hydroxy cinnamic acid-peptide derivatives, including a caffeic acid-proline-histidine hybrid (p. 7-8, Example 3, English translation) prepared by reacting hydroxy cinnamic acids with a proline-histidine dipeptide (p. 7, Examples 1-2, English translation) which confers the following structure as provided by STN (see Examiner’s search strategy).
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The compound is within the scope of the claims wherein L is alkylene (ethylene, see instant specification cited above), R1 is phenyl disubstituted by hydroxyl, R2 is imidazolyl or indolyl, R3 is amino, and R4 is hydrogen. Lee et al. additionally discloses that the compounds have antioxidant properties for use in skin whitening and aging prevention (Abstract, English translation). As discussed in the above 112(d) rejection, the intended use of the compounds and compositions thereof is not given substantial patentable weight. Moreover, per MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).” As such, the properties recited in claims 8 and 9 would be expected to be shared by the compounds of Kwak et al. which are substantially identical to the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.E.B./Examiner, Art Unit 1624 05/05/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
Prosecution Insights